How to Test an IRT: A Primer for Users, Part II

IRT Essentials

You’ve worked through the user requirements for your clinical project and how it will be implemented by your Interactive Response Technology (IRT/IWR/IVR) vendor. Your vendor has built the system and completed their verification testing to confirm it meets user specifications (see How to Test an IRT, Part I). Presumably your team has also had a chance to join the vendor for an informal walk-through of the system to confirm, in global terms, that it correctly supports your project.

Now it’s time for you to complete your User Acceptance Testing (UAT) to validate the project IRT.

Practical IRT Design from Veracity Logic

IRT Essentials, White Papers

“Configurable” and “modular” are claims made by many companies providing clinical IRT (IWR/IVR) services today. Configurable means that system changes can be made to meet the specific needs of a clinical trial without requiring days of coding by a vendor’s development and technical support team. Modular means clients only pay for the functionality they need. Veracity Logic’s VLIRT® solution is built on a configurable, modular foundation that is technology agnostic for integration with other eClinical systems.

How to Test an IRT: A Primer for Users, Part I

IRT Essentials

Regulatory requirements and plain old common sense make the documented testing and validation of the electronic systems used in clinical trials of critical importance to the success of any clinical study. To put it bluntly, approval authorities around the world will reject clinical data collected by what regulators deem to be substandard means (see, e.g., 21CFRPart11, EU Annex 11, etc)
Veracity Logic is an exclusive IRT (IWR/IVR) vendor, so let’s get into the nitty-gritty of what this means for IRT systems.

Play It Again, Sam: Why Use an IRT?

IRT Essentials

We sometimes hear spirited discussions at industry conferences between Sponsors who can’t imagine executing their clinical trials without including an IRT (IWR/IVR) system in the technology mix, and Sponsors who remain partial to things like randomization houses, spreadsheets (still!), supplier-direct approaches, and the like.

Two misconceptions on the part of IRT-naysayers are immediately obvious to observers of this phenomenon:
• The belief that IRTs are always ‘expensive’ – (no, they’re not)
• The belief that IRTs are very limited in what they can do – in essence, are just a way-more-expensive way to randomize subjects – (no, they’re not)

We’ve Got You Covered: Countries

IRT Essentials

Interactive Response Technology solutions must reach people wherever they are throughout the world. Subjects/Patients, Clinical Sites Users, Warehouse Distribution Staff, and the Clinical Project Teams exist in a more and more distributed environment. Veracity Logic’s web presence exists anywhere users are able to reach the Internet. Our Help Desk staff are available to all users via email or phone.

In addition, we have phone lines available in 50+ countries including:

We’ve Got You Covered: Languages

IRT Essentials

Interactive Response Technology solutions must be able to provide notifications in multiple languages as needed based on the countries in which a study is conducted. For IVR (phone) systems, voice prompts must also be translated and recorded in the needed languages.

We’ve got you covered! Veracity Logic supports over 40 languages including:

Complex Warehousing and Regional Depots…

Case Studies

Problem:

You’ve got a large, complex clinical study to be conducted at 120 sites in 22 countries around the world, with four treatment groups and two ancillary products required for the trial at all locations. Logistics of manufacture and distribution make it clear the most cost-effective solution is to have centralized warehousing in the US for two of the study drugs, in the UK for the other two study drugs, and that all ancillary supplies should best come from a warehouse in Germany! But your current IRT can’t handle the complex shipping and inventory management required for such an array. What to do?
Solution:

Veracity Logic’s IRT has been designed to accommodate a wide variety of warehousing and distribution scenarios. For the case above, a central warehouse in the US and a central warehouse in the UK could directly supply one another with study drug, while each warehouse then managed the distribution of all four drugs to multiple depots positioned in EU and North America respectively. In addition, a regional depot in Mumbai (supplied by the UK warehouse) would feed clinical sites in India. A warehouse in Germany would be established to handle the distribution of ancillary supplies direct to all depots in all locations, for distribution to sites. The VL IRT Inventory Management module and Shipment modules would keep all the counts and details in sync.

Got a complex scenario for drug distribution?